Zenith Goldline Pharmaceuticals; Withdrawal of Approval of 11 Abbreviated Antibiotic Applications and 105 Abbreviated New Drug Applications

الملخص

The Food and Drug Administration (FDA) is withdrawing approval of 11 abbreviated antibiotic applications (AADA's) and 105 abbreviated new drug applications (ANDA's). Zenith Goldline Pharmaceuticals notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.